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Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
• By Dexter Jie Yan

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

An equal allocation of study populations in multiregional trials is set to become a major hurdle for sponsors. (Shutterstock)

Elevar Therapeutics, a US subsidiary of South Korea’s HLB LifeScience, and China’s Jiangsu Hengrui Pharmaceuticals on 21 March received a complete response letter from the US Food and Drug Administration on the pair’s resubmitted new drug application for a combination therapy for a form of liver cancer with a higher prevalence in Asian populations.

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